Factors influencing the outcome of nilotinib treatment in patients with chronic myeloid leukemia in daily practice
Completed
- Conditions
- Chronic Myelogenous LeukemiaCancer of white blood cells10024324
- Registration Number
- NL-OMON41699
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
Inclusion Criteria
- Male or female patients >= 18 years of age
- ECOG 0, 1, or 2.
- Diagnosis of chronic myelogenous leukemia with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations.
- Treatment with nilotinib.
Exclusion Criteria
- Inability to grant consent.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy endpoint is the MMR within 12 months after the start of<br /><br>first study medication. A MMR is defined as <=0.1% BCR-ABL/ABL in the<br /><br>international scale.<br /><br>The primary means of assessing adherence is the total intake of nilotinib<br /><br>capsules as counted by means of a medication event monitoring system, taken as<br /><br>percentage of the number of capsules prescribed over the 12 months follow-up<br /><br>period.</p><br>
- Secondary Outcome Measures
Name Time Method